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U.S. Department of Health and Human Services

Product Classification

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Device breast milk-alcohol test system
Regulation Description Alcohol test system.
Definition Is intended for use by consumers at home as a qualitative test to identify the presence of alcohol in breast milk.
Physical State Should not include serum, plasma or urine
Technical Method Intended to detect the presence of alcohol in breast milk. the test utilizes an emzymatically catalyzed reaction of ethyl alcohol in the presence of oxygen to produce hydrogen peroxide. The peroxide produced along with a dye substrate, are enzymatically catalyzed with peroxidase to form a colored gree/blue dye. The initial reaction is catalyzed by alcohol oxidase enzyme produced from yeast whixh is specific to ethonal, methanol, isopropanol and will not react with alcohol having five or more carbons or with glycine, glycerol or serine.
Target Area Breast milk
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeORA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.3040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible